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Survey of Preferences Regarding Spinal Implants
Rochester, MN
The purpose of this study is to evaluate patient and parent willingness to participate in a proposed randomized controlled trial evaluating a low vs. high implant density for surgical treatment of scoliosis.
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Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
Rochester, MN
The purpose of the present study is to quantify the degree of modulation, if any, in the perioperative inflammatory response associated with statins use. Specifically, we hypothesize that:
In a population of patients undergoing elective orthopedic spine surgery, administration of a specific statin (Simvastatin, Zocor®, Merck Pharmaceuticals), will be associated with a decrease in perioperative inflammatory markers when compared to patients not taking statins
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A Study of Lofexidine for Rapid Opioid Tapering in Adults
Rochester, MN
The purpose of this study is to assess the effects of lofexidine on opioid tapering in adults undergoing opioid tapering prior to elective lumbar spine surgery.
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A Study to Evaluate the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact (P080013b) as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact.
Subjects who have consented to participate in this study prior to undergoing spinal surgery and experience a durotomy, will be considered for study enrollment.
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Cortical versus Pedicle Screw Stimulation Thresholds and Accuracy
Rochester, MN
The purpose of this study is to compare the stimulation threshold and accuracy of pedicle versus cortical trajectory screws
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A Mobile Application for Next Generation Patient Evaluation, Follow-Up, and Outcomes Monitoring
Rochester, MN
The purpose of this study is to:
1. To use natural language processing techniques applied to Twitter posts during a 1 month pre and 3 month postoperative surveillance of patients undergoing spine surgery in an effort to identify risk of 30-day postoperative complications, as well as long-term improvement in symptoms.
2. To use signal processing analytics applied to mobility data gathered from smartphone accelerometers (e.g. iPhone health app) during a 1 month pre and 3 month postoperative surveillance of patients undergoing spine surgery in an effort to identify risk of 30-day postoperative complications, as well as long-term improvement in symptoms.
3. To correlate ...
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Scoliosis Shared Decision Making
Rochester, MN
Analysis of video encounters between providers, patients, and families will be used to develop a shared decision making tool for patients deciding between surgery and observation for scoliosis treatment.
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Molecular Characterization of Spinal Tissue
Rochester, MN
The researchers are trying to identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.
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Study of Lumbar Discectomy with Additional Implantation of an Annular Closure Device in Patients with Large Postsurgical Annular Defects
Jacksonville, FL
The purpose of this study is to confirm the efficacy of the Barricaid® when used as an adjunct to a primary lumbar limited discectomy, to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction in a US population.
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A Study Comparing Effectiveness and Safety of SPIRA-A Anterior Lumbar Interbody Fusion Device to PEEK Anterior Lumbar Interbody Fusion Cage with rhBMP-2 in Instrumented Lumbar Fusions
Rochester, MN
The purpose of this study is to evaluate if SPIRA-A Anterior Lumbar Interbody Fusion Device is equivalent in effectiveness and safety to PEEK Anterior Lumbar Interbody Fusion Cage with rhBMP-2 when used in instrumented lumbar fusions.
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A Study of the Effectiveness of EXPAREL for Pain Control in Adult Subjects Undergoing Open Lumbar Spinal Fusion Surgery
Rochester, MN
The purpose of this study is to compare postsurgical pain control following local infiltration analgesia and bupivacaine HCl with EXPAREL, versus without EXPAREL, in adult subjects undergoing open lumbar spinal fusion surgery. The study will also compare additional effectiveness, safety, and health economic outcomes.
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Evaluating Adult Patient Temperatures During Lower Spinal Surgery
Rochester, MN
The purpose of this study is to evaluate patients' temperatures after using one of two ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™ system) or the standard ventilator circuit with a heat-moisture exchanger (standard ventilator). The ANAPOD™ system will provide additional heat and humidity to patients through their breathing tube while the standard ventilator will not. The investigators are doing this research study to find out if the ventilator circuit providing additional heat and humidity will keep patients warmer during surgery and after surgery.
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A Study to Compare Outcomes of Decompression Alone and Decompression and Fusion in Patients with a Recurrent Disc Herniation
Rochester, MN
The purpose of this study is to compare outcomes of decompression alone and decompression and fusion for patients with a recurrent disc herniation.
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A Study to Evaluate Awake vs. Asleep Spine Surgery
Jacksonville, FL
Patients undergoing spine lumbar surgery will be asked to perform short exams/questionnaires aimed at determining cognitive function, quality of life, health outcomes twice post surgery with a baseline performance prior to surgery.
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A Study of Bowel Function Return After One or Two Level Anterior Lumbar Interbody Fusion with Chewing Gum
Scottsdale/Phoenix, AZ
The purpose of this study is to observe changes in bowel pattern based on gum-chewing, examine bowel function after anterior lumbar interbody fusion, measure length of time to return of bowel function after anterior lumbar interbody fusion, compare return of bowel function in patients who chew gum and patients standardized to usual post-operative care, measure the hospital length of stay amongst study groups, and measure post-operative pain amongst study groups.
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Safety and Effectiveness Study of the Precision SCS System Adapted for High-Rate Spinal Cord Stimulation
Rochester, MN
To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator System Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain
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A Study of Molecular Characterization of Spinal Tissue
Rochester, MN
The purpose of this study is to identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.
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A Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Rochester, MN
The primary purpose of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL group) with that of patients receiving standard of care (SOC) (control group) in adult subjects undergoing posterior lumbar spine surgeries where both groups are receiving a multimodal pain regimen.
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Pediatric Idiopathic Scoliosis Preference Study of Motion Sparing Spinal Growth Modulation versus Spinal Fusion
Rochester, MN; Minneapolis, MN
The purpose of this study is to administer a patient preference survey that will be used to understand patient preferences in scoliosis treatment, specifically fusion versus nonfusion surgical treatment approaches.
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A Study to Evaluate the Treatment of Lumbar Spinal Stenosis (LSS) with the MILD Procedure
Rochester, MN
The purpose of this study is to examine functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control.
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A Study to Evaluate Post-surgical Outcomes Using the Early Recovery After Surgery (ERAS) Protocol for Posterior Cervical Decompression and Fusion
No Locations
The purpose of this study is to examine the role of an Early Recovery After Surgery (ERAS) protocol designed for posterior cervical spinal fusion.
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A Study to Establish a Pediatric Spine Registry
Rochester, MN; Minneapolis, MN
The purpose of this study is to collect data about patients with chest wall and spinal deformities to develop a multicenter registry. This will speed the pace of medical advancement and treatment recommendations for these conditions.
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Study to Evaluate the Utility, Safety, Effectiveness, and Cost of Physical Therapy on Elective Spine Surgery Patients
Jacksonville, FL
The purpose of this study is to evaluate the utility, safety, effectiveness, and cost of physical therapy on elective spine surgery patients.
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A Study to Assess Wound Closure Techniques in Primary Spine Surgery Using SPY Intra-operative Angiography
Rochester, MN
The purpose of this study is to assess wound perfusion at the site of closure in primary spine surgery between running subcuticular suture, interrupted vertical mattress suture, and staple closure techniques.
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A Study of Noninvasive Hemoglobin Monitoring in Pediatric Patients Undergoing Orthopedic Surgery
Rochester, MN
The purposes of this study are to validate noninvasive hemoglobin monitoring in postoperative orthopedic pediatric patients, to evaluate patient, parent, and provider preference of noninvasive hemoglobin monitoring compared to invasive blood draw, and to evaluate cost effectiveness of noninvasive monitoring in comparison to invasive blood draws.
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Epidural and Dorsal Root Stimulation in Humans with Spinal Cord Injury
Rochester, MN
A study to compare electrophysiologic activity of epidural stimulation and dorsal root ganglion stimulation, as well as quantify changes in motor performance with both types of stimulation over the course of 10 rehabilitation sessions.
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A Study to Use a Patient Monitoring Application that Monitors Physiological Data, Psychosocial Data, and Responses to Survey Questions in Patients Undergoing Cranial or Spinal Surgery
Rochester, MN
The purpose of this study is to use a patient monitoring application that monitors physiological data, psychosocial data, and responses to survey questions collected during a one month pre and three and six month postoperative observation period.